Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Lamisil Once
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Terbinafine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR Lamisil ONCE is a single dose treatment for tinea pedis (athlete's foot). Lamisil ONCE works by killing the fungus which causes tinea pedis (athlete's foot). When it's applied to the feet, it leaves a colourless film that stays on the skin delivering the active substance into the skin. How you know that you have tinea pedis (athlete's foot) Tinea pedis (athlete's foot) appears only on the feet. It often starts between the toes, but it can also spread to the soles and sides of the feet. The most common type of tinea pedis (athlete's foot) causes cracking or scaling of the skin. You may also have mild swelling, blisters, or weeping sores. This may often be associated with an itching or burning feeling. If you are not sure whether your symptoms are really due to tinea pedis (athlete's foot), talk to your doctor or pharmacist, before using Lamisil ONCE. If you are diabetic you should visit your healthcare professional for regular check ups as diabetes can increase the risk of foot problems.
This medicine should be used with caution in patients with lesions where alcohol could be irritating. For example, after sun exposure or in case of severe skin scaling. For external use only. Do not swallow. Keep away from naked flames (contains alcohol). Using other medicines Do not apply other medicines or treatments to your feet (including any you have bought without a prescription) at the same time as Lamisil ONCE. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any you have bought without a prescription. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Lamisil ONCE while breast-feeding, as terbinafine is excreted in breast milk. Driving and using machines The use of Lamisil ONCE does not affect the ability to drive and use machines. Important information about some of the ingredients of Lamisil ONCE Lamisil ONCE contains 3316.8 mg alcohol (ethanol) in each daily dose which is equivalent to 863.75 mg/g of 96% ethanol. It may cause burning sensation on damaged skin.
3. HOW TO USE LAMISIL ONCE For adults only. Do not use on patients under 18. Apply only once. Do not apply it a second time. You must apply Lamisil ONCE to both feet, even if signs are visible only on one foot. This is to make sure you get rid of the fungus completely: it could be prnt in other parts of the feet even if there are no visible signs of it. When applied to the feet, the medication dries quickly to a colourless film. The tube has enough medication to treat both feet. Lamisil ONCE delivers the active ingredient into the skin where it lasts for a number of days to kill the fungus that causes athlete's foot.
24
1
HRS
TIME USE
2. BEFORE YOU USE LAMISIL ONCE Do not use Lamisil ONCE: If you are allergic (hypersensitive) to terbinafine or any of the other ingredients of this medicine (listed over the page at the end of Section 6). Take special care with Lamisil ONCE Children and adolescents under 18 are not to use this medicine, since there is not enough experience. If you suffer from long-term fungal infection of the soles and heels of the feet with thickened and/or obviously flaky skin, do not use this medicine. Tell your doctor if you think you may have this condition, because you may need another medicine. Only use this medicine to treat the skin of your feet. Be careful not to get it on your face, in your eyes, or on damaged skin (other than at the treatment site) where it could be irritating. If it accidentally gets into your eyes, rinse thoroughly with running water. See your doctor if you are still in any discomfort.
Apply to
BOTH
FEET
To get the best results, do not wash or splash your feet for 24 hours after applying it. When to use It is best to apply Lamisil ONCE after a shower or a bath.
How to take it
This is a single application treatment. Wash both feet and dry them carefully. Wash and dry your hands. Remove the cap from the tube. Apply to both feet – use about half the tube for each foot, as needed to cover skin. Finish one foot before treating the other. Apply with fingers to each foot as shown above. Spread evenly onto the skin between, under, and over all toes. Then apply over the sole and sides of your foot. Do not rub or massage it in. Treat the other foot in the same way, even if the skin looks healthy. This is to make sure you get rid of the fungus completely – it could be on the other foot even if there are no signs of it. 2003479_1/62000000208874
Leave it to dry to a film for 1 to 2 minutes, before wearing your normal footwear. Replace the cap on the tube and throw away any remaining product. Do not keep or give any remaining product to other people. Wash your hands with warm soapy water after the application. Do not wash or splash your feet for 24 hours after applying Lamisil ONCE. Gently pat dry your feet after gentle washing. Do not apply it a second time. Lamisil ONCE will start to kill the fungus immediately. The film that is formed means the active ingredient penetrates your skin where it continues to work for several days. Your skin should start to improve within a few days, but it may take up to 4 weeks for your skin to heal completely. If you have not noticed any signs of improvement within 1 week after applying Lamisil ONCE, ask your doctor or pharmacist for advice. Do not use the product a second time for a particular athlete's foot episode if it did not work after the first application. To help with treatment Keep the affected area clean by washing it reguarly after the first 24 hours. Dry it carefully without rubbing. Although the skin may be itchy, try not to scratch it because this could cause more damage and slow the healing process or spread the infection. Use your own towel and clothes and don't share them with other people because athlete's foot can be passed on easily. Wash your clothes and towels frequently to protect yourself from re-infection. What if you accidentally swallow some of the product. Tell your doctor who will advise you what to do. What if you accidentally get the product on your face or in your eyes Rinse your face or eyes thoroughly with running water. See your doctor if you are still in any discomfort.
Possible side effects
Like all medicines, Lamisil ONCE can cause side effects, although not everybody gets them. STOP using Lamisil ONCE and seek medical help immediately if you have any of the following very rare allergic reactions: Difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (severe allergic reaction) Severe itching of the skin, with a red rash or raised lumps, hives or blisters. Uncommon (may affect up to 1 in 100 people): application site reactions, which may include skin dryness, skin irritation or burning sensation, after application. They are usually mild, temporary and harmless. Very rare (may affect up to 1 in 10,000 people): allergic reactions with rash, itching, blistering of the skin and hives. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
2003479_1/62000000208874
How to store it
LAMISIL ONCE
Keep out of the sight and reach of children. Do not use Lamisil ONCE after the expiry date stated on the box and on the tube. The expiry date refers to the last day of that month. Store in the original package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Lamisil ONCE contains Do not use Lamisil ONCE if you are allergic to any of these ingredients. The active substance is terbinafine (as hydrochloride). Each gram of cutaneous solution contains 10 mg of terbinafine (as hydrochloride). The other ingredients are acrylates/octyl-acrylamide copolymer, hydroxypropylcellulose, medium chain triglycerides and ethanol. What Lamisil ONCE looks like and contents of the pack Lamisil ONCE is a clear to slightly cloudy gel-like solution. It is available in tubes of 4g. Marketing Authorisation Holder: Karo Healthcare AB Box 16184 103 24 Stockholm Sweden Manufacturers: Karo Healthcare AB Klara Norra Kyrkogata 33 111 22 Stockholm Sweden This leaflet was last revised December 2023.
Frequently asked questions about Lamisil Once
What is the active substance in Lamisil Once?
The active substance in Lamisil Once is terbinafine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lamisil Once, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Lamisil Once without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: terbinafine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment for tinea pedis (athlete's foot).
Lamisil Once 1% cutaneous solution is indicated for Adults 18 years of age and over.
4.2. Posology and method of administration
For Cutaneous Use
Adults 18 years of age and over: single administration.
Duration and frequency of treatment
Lamisil Once 1% cutaneous solution should be applied once on both feet, even if lesions are visible on one foot only. This ensures elimination of the fungi (dermatophytes) that might be found in areas of the foot where no lesions are visible.
Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after one week, patients should see a doctor. There are no data on repeated treatment with Lamisil Once 1% cutaneous solution.
Therefore a second treatment cannot be recommended within a particular episode of athlete's foot.
Dosing in special populations
Paediatric population
Lamisil Once 1% cutaneous solution has not been studied in the paediatric population. Its use is therefore not recommended in patients below 18 years of age.
Elderly patients
There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.
Method of Administration
Patients should wash and dry both feet and hands before applying the product. They should treat one foot, then the other.
Starting between the toes, patients should apply a thin layer evenly between and all around the toes, as well as cover the sole and sides of the foot for up to 1.5 cm. The product should be applied in the same way to the other foot, even if the skin looks healthy. The product should be left to dry to a film for 1-2 minutes. Patients should then wash their hands. Lamisil Once 1% cutaneous solution should not be massaged into skin.
For the best results, the treated area should not be washed for 24 hours after application. It is therefore recommended to apply Lamisil Once 1% cutaneous solution after a shower or bath and wait until the same time the following day before washing the feet again.
Patients should use the quantity they need to cover both feet as instructed above. Any unused medication is to be discarded.
4.3. Contraindications
Hypersensitivity to terbinafine or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Lamisil Once 1% cutaneous solution is not recommended to treat hyperkeratotic chronic plantar tinea pedis (moccasin type).
Lamisil Once 1% cutaneous solution:
• Should be used with caution in patients with lesions where alcohol could be irritating (after sun exposure or severe skin scaling).
• Should not be used on the face.
• For external use only.
• May be irritating to the eyes. In case of accidental contact with the eyes, rinse eyes thoroughly with running water/
This medicine contains 3316.8 mg alcohol (ethanol) in each daily dose which is equivalent to 863.75 mg/g of 96% ethanol. It may cause burning sensation on damaged skin.
Do not swallow.
Keep out of sight and reach of children.
In the event of allergic reaction, the film should be removed with an organic solvent such as denatured alcohol and the feet washed with warm soapy water.
• Keep away from naked flames.
4.5. Interaction with other medicinal products and other forms of interaction
No drug interactions are known with the use of topical forms of terbinafine.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no clinical experience with terbinafine in pregnant women. Foetal toxocity and fertility studies in animals suggest no adverse effects (see section 5.3).
Lamisil Once 1% cutaneous solution should not be used during pregnancy unless clearly necessary.
Lactation
Terbinafine is excreted in breast milk.Lamisil Once 1% cutaneous solution should not be used during breast-feeding.
Fertility
No effect of terbinafine on fertility have been seen on animal studies (see section 5.3).
4.7. Effects on ability to drive and use machines
Lamisil Once 1% cutaneous solution has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
Undesirable effects include mild and transient reactions at the site of application. In very rare instances, allergic reactions may occur.
Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Description of selected adverse reactions
Skin and subcutaneous tissue disorders:
Very rare (<1/10,000, including isolated reports): allergic reactions such as rash, pruritus, dermatitis bullous and urticaria.
General disorders and administration site conditions
Uncommon (>1/1,000, <1/100): application site reactions such as skin dryness, skin irritation or burning sensation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uklyellowcard.
4.9. Overdose
Symptoms
Overdose is very unlikely to happen since the product is for single dose, cutaneous use, and the tube only contains the necessary quantity for one application.
Accidental ingestion of one 4 g tube of product contains 40 mg terbinafine which is much lower than one 250 mg Lamisil tablet (oral unit dose).
Should several tubes of Lamisil Once 1% cutaneous solution be inadvertently ingested however, adverse effects similar to those observed with an overdose of Lamisil tablets, are to be expected. These include headache, nausea, epigastric pain and dizziness.
In case of accidental oral ingestion, the alcohol content 81.05% w/w of Lamisil Once 1% cutaneous solution has to be considered
Management
If accidentally ingested, the recommended treatment of overdosage consists of eliminating the active substance, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if needed.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- FUNGISIL MK 10 mg/g over the counterTERBINAFINUM · skin / topical
- TERBINAFINA ARENA 250 mg prescriptionTERBINAFINUM · taken by mouth
- LAMISIL 10 mg/g over the counterTERBINAFINUM · skin / topical
- EXOTERFYN 78,22 mg/ml over the counterTERBINAFINUM · skin / topical
- TAFICEN 10 mg/g over the counterTERBINAFINUM · skin / topical
- TERBINAFINA OZONE 10 mg/g over the counterTERBINAFINUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- LamisilattTerbinafini hydrochloridum
- LamisilTerbinafini hydrochloridum · taken by mouth
- TerbidermTerbinafini hydrochloridum
- MyconafineTerbinafinum · taken by mouth
- Undofen MaxTerbinafini hydrochloridum
- ErfinTerbinafinum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Lamisil Once. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.